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Pfizer Global Regulatory Affairs
Pfizer Inc .
235 East 42ndStreet /New York , NY 10017 -5755
Global Product Developm ent
31March 2021
Marion Gruber, Ph.D.
Director
Office of Vaccines Research and Review
Food and Drug Administration
Center for Bi ologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL
AND/OR TRADE SECRET INFORMATION
THAT IS DISCLOSED ONLY IN CONNECTION
WITH THE LICENSING AND/OR
REGISTRATION OF PRODUCTS FOR PFIZE R
INC OR ITS AFFILIATED COMPANIES. THIS
DOCUMENT SHOULD NOT BE DISCLOSED OR
USED, IN WHOLE OR IN PART, FOR ANY
OTHER PURPOSE WITHOUT THE PRIOR
WRITTEN CONSENT OF PFIZER INC.
SN0267
Re: Covid-19 Vaccine (BNT162/PF -07302 048) BB-IND 19736
IND Amendment –
Post-authorization Vaccine Effectiveness Studies : Study C4591014,
WI235284, WI255886 Protocol s
Statistical Analysis Plan for Study WI255886
Dear Dr. Gruber ,
Reference is made to BB-IND 19736 for the COVID -19 vaccine (BNT162; PF -07302048),
which Pfizer and BioN Tech are developing for the prevention of COVID -19 in a dults ≥16
years of age. The IND was effective on April 29, 2020. Further references is made to the
Emergency Use Authorization (EUA 27034 )that was granted for this vaccine (Pfizer -
BioNTech COVID -19 Vaccine) on 11 December 2020 , the agreed Pharmacovigilence Plan,
and the Request for Comments and Advice submitted 22 Febru ary 2021 to BB -IND 19736
(SN 224) regarding Pfizer -BioNTech’s commitment to evaluate vaccine e ffectiveness.
The present submission provides final protocol sfor three post-authorization studies to
evaluate vaccine effectiveness (test negative design) of BNT162b2 , as described in the 22
February 2021 Request ,in Module 5.3.5.4. Pfizer/BioNTech have incorp orated feedback
received from CBER ’s05 March 2021 Response to the 22 Febru ary 2021 Request .
WI235284 entitled, “Respiratory Syncytial Virus (RSV) in Older Adults and Pregnant
Women Study (ROAPS) ”Amendment f or BNT162b2 Post -authorization Vaccine
Effectiveness -Pfizer -Emory Research Collaboration
oPfizer has been engaged in a research collaboration with Emory University ,
who is the sponsor of the study ,to conduct prospective surveillance for RSV
FDA-CBER-2021-5683-1072493
Marion Gruber, Ph.D. , Director Page 2of 3
BB-IND 19736 31March 2021
Pfizer Confid ential
Page 2in older adul ts and pregnant women hospitalized with a cute respiratory
infection (ROAPS) since 2018. Study WI235284 is a prop osed amendment to
the ROAPS protocol which includes the required study design element s
necessary to perform the test -negative design VE analyses of BNT162b2 that
Pfizer has planned. Tomaintain document continuity for the Emory IRB, the
COVID VE stud y desi gn elements have been incorporated and labeled as
COV ID VE / Substudy 6 . The aim of this amendment is to continue the
ROAPS study and the associated Substudies 1-5, and to implement t he
COVID VE Substudy 6 pending agreement with the Regulatory Authorities
and approval from the Emory IRB.
WI255886 entitled, “A Pan-pandemic Acute Lower Res piratory Tract Disease
(LRTD) Surveillance Study (AVONCap) ”Amendment for BNT162b2 Post -
authorizati on Vaccine Effectiveness -Universit y of Bristol (UK): Pfizer -Emory
Research Collaboration
oPfizer has also been engaged in a research collaboration with the University of
Bristol , a site that was deemed a Vaccine Research Centre of Excellence by
Pfizer as an expression of the intention to form a longstanding research
partnership. The first study in this collaboration was of adults hospitalized
with lower respi ratory tract disease which has been recruiting participants
since 2020. The University of Bristol is the sponsor of the stud y. Study
WI255886 is a proposed amendment to the AVONCap protocol which
includes the required study design elements necessary to per form the test -
negative design VE analy ses of BNT162b2 that Pfizer has planned. Alongside
the protoc ol, which contain ssummary information in accordance with site -
defined requirements, the statistica lanaly sis plan for this study is also
enclosed in this su bmission. Chapter 2 of the statistical anal ysis plan includ es
detailed information about the planne d BNT162b2 VE analyses.
C4591014 entitled, “Pfizer- BioNTech COVID -19 BNT162b2 Vaccine Effectiveness
Study - Kaiser Permanente Southern California”
oPfizer is the sponsor of Study C4591014
The same information is being submitted to BB -IND 19736 and EUA 27034 in parallel.
This su bmission has be enscanned for vir uses us ing Mc Afee VirusS can En terprise Version
8.8 and is vi rus free . The submission is being s ent via the Gateway .
Should you have an y questio ns regarding t his submi ssion, or requi re additional information,
pleasecontact me via phone a t 212-733-2613 ; via facsimile at 845 -474-3500; or via e -mail at
neda.aghaj animem [email protected] .
Sincerel y,
Neda Aghaja ni Memar, Pharm.D.
Director
FDA-CBER-2021-5683-1072494
Marion Gruber, Ph.D. , Director Page 3of 3
BB-IND 19736 31March 2021
Pfizer Confid ential
Page 3Pfizer Global Regulatory Affairs
CC: Ramachandra S. Naik, Ph.D.
FDA-CBER-2021-5683-1072495